MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97702

Device Problems Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Abrasion (1689); Fall (1848); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported that a patient had a shocking or jolting sensation.It was stated that the patient met with a manufacturer¿s representative (rep) months ago and she got ¿zapped¿ by the device and fell out of her truck flat on her face on the concrete.It was stated that the patient had a cut knee and cut hand.It was further reported that after a (b)(6) reprogramming, when the patient stood up she would get a ¿jolt¿ and would get sprung forward.It was stated that at one point the rep put all the electrodes on cycling mode, and the patient stated that she couldn¿t handle the cycling because it ¿gave her the ¿jibber jabbers¿ everywhere¿.Additional information received reported that the patient¿s rep told her he would try to reset her device but the patient reported that she had her therapy reset ¿10 times now¿.The patient expressed concern that there was something wrong with the system¿s components on her left side due to a fall.It was stated that the patient wanted to know if her stimulation system was ¿ok¿ on her left side.

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 977a260,serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 97740, lot# serial# (b)(4), product type: programmer, patient.(b)(4).

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3756917
• MDR Text Key: 14874287
• Report Number: 3004209178-2014-07433
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2014
• Initial Date FDA Received: 04/17/2014
• Date Device Manufactured: 06/06/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00050 YR